FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer.
Melanie E RoyceChristy OsgoodFlora MulkeyErik BloomquistWilliam F PierceArpita RoyShyam KalavarSoma GhoshReena PhilipFatima RizviBronwyn D MixterShenghui TangRichard PazdurJulia A BeaverLaleh Amiri-KordestaniPublished in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2022)
The approval of abemaciclib in adjuvant EBC was limited to patients with high risk of recurrence and Ki-67 ≥ 20%, given their favorable benefit:risk with a statistically significant IDFS advantage and no observed detriment on survival.